Welcome to our dedicated page for AstraZeneca news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on AstraZeneca stock.
AstraZeneca PLC (AZN) generates a steady flow of news driven by its global biopharmaceutical activities in Oncology, Rare Diseases and BioPharmaceuticals. Company announcements frequently cover clinical trial milestones, regulatory decisions, manufacturing investments and strategic collaborations, offering investors and healthcare professionals insight into how its pipeline and marketed medicines are evolving.
Recent news highlights include multiple updates on Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan), two antibody drug conjugates jointly developed with Daiichi Sankyo. These stories describe new Phase 3 trials, Breakthrough Therapy Designations, and approvals in indications such as HER2-positive early breast cancer, metastatic breast cancer, HER2-expressing endometrial cancer and HER2-expressing ovarian cancer, as well as TROP2-directed approaches in lung and breast cancer.
News items also cover immuno-oncology developments with Imfinzi (durvalumab), including perioperative regimens for gastric and gastroesophageal junction cancers based on the MATTERHORN trial, and broader use in gastrointestinal and thoracic malignancies. In Rare Diseases and immunology, AstraZeneca reports on approvals for Koselugo in adult NF1-associated plexiform neurofibromas and on expanded administration options for Saphnelo in systemic lupus erythematosus.
Beyond clinical and regulatory updates, AstraZeneca’s news feed includes information on large-scale manufacturing investments in the United States, such as expansion of biologics facilities in Maryland, and technology partnerships like the selection of Salesforce’s Agentforce Life Sciences platform for AI-powered customer engagement. Visitors to this AZN news page can review these developments to understand how AstraZeneca’s pipeline, approvals and infrastructure may influence its long-term strategic direction.
AstraZeneca (NYSE:AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) received Breakthrough Therapy Designation (BTD) in the US on December 22, 2025 for adult patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment and high risk of recurrence.
The FDA decision was based on positive DESTINY-Breast05 Phase III results presented at ESMO 2025 and published in The New England Journal of Medicine. This marks ENHERTU's tenth BTD and targets the post-neoadjuvant setting to reduce invasive disease recurrence.
AstraZeneca (AZN) and collaborators have dosed the first patient in the DESTINY-Endometrial02 phase 3 trial testing ENHERTU® (trastuzumab deruxtecan) as adjuvant therapy versus standard chemotherapy, with or without radiotherapy, for patients with HER2 expressing (IHC 3+/2+) endometrial cancer.
The global trial is conducted with The GOG Foundation and ENGOT (lead group GINECO). ENHERTU is co‑developed with Daiichi Sankyo. The release notes HER2 expression in ~18%–56% of endometrial cancers and a 39%–56% 18‑month recurrence/death rate in high‑risk patients after standard adjuvant care. There are currently no approved HER2 directed adjuvant therapies for this indication.
ENHERTU (AstraZeneca: AZN) received U.S. Breakthrough Therapy Designation on December 22, 2025, for adult patients with HER2 positive early breast cancer with residual invasive disease after neoadjuvant therapy and high recurrence risk.
The FDA granted BTD based on the DESTINY-Breast05 phase 3 results presented at ESMO 2025 and published in The New England Journal of Medicine, which showed ENHERTU may reduce invasive disease recurrence versus the current standard of care. This is ENHERTU's tenth BTD and the sixteenth BTD across Daiichi Sankyo's oncology portfolio.
AstraZeneca (AZN) and Daiichi Sankyo announced the European Medicines Agency has validated a Type II Variation application for DATROWAY (datopotamab deruxtecan) as first-line monotherapy for adults with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors.
The application, based on the pivotal TROPION-Breast02 phase 3 trial presented at ESMO 2025, showed statistically significant improvements in overall survival (OS) and progression-free survival (PFS) versus investigator's choice chemotherapy. Validation starts the EMA scientific review; additional global submissions are underway.
AstraZeneca (AZN) and Daiichi Sankyo announced US FDA approval (Dec 15, 2025) of ENHERTU (fam-trastuzumab deruxtecan-nxki) plus pertuzumab as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer. Approval is based on DESTINY-Breast09 Phase III results showing a 44% reduced risk of progression or death (HR 0.56; 95% CI 0.44–0.71; p<0.0001) and a median PFS of 40.7 months vs 26.9 months for THP. Safety was consistent with known profiles. A $150m milestone payment from AstraZeneca to Daiichi Sankyo is due following US approval.
AstraZeneca (AZN) and Daiichi Sankyo announced U.S. FDA approval of ENHERTU plus pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2 positive breast cancer, based on DESTINY-Breast09 phase 3 results.
The trial showed a 44% reduction in risk of progression or death (HR 0.56; 95% CI 0.44-0.71; p<0.0001), median PFS of 40.7 months vs 26.9 months for THP, ORR 87% vs 81%, and confirmed CR rates 15% vs 8%. Safety included Boxed WARNINGS for ILD/pneumonitis and embryo-fetal toxicity; serious adverse reactions occurred in 27% and fatalities in 3.4% of patients. A $150 million milestone from AstraZeneca to Daiichi Sankyo is payable following approval.
AstraZeneca (AZN) announced on December 9, 2025 that the first patient has been dosed in the randomized phase of the DESTINY-Ovarian01 phase 3 trial. The study is evaluating ENHERTU (trastuzumab deruxtecan) plus bevacizumab versus bevacizumab monotherapy as first-line maintenance after platinum-based chemotherapy with bevacizumab in patients with HER2 expressing (IHC 3+/2+/1+) advanced high-grade epithelial ovarian cancer.
The trial is conducted with ENGOT partners (GEICO lead), GOG-F, and APGOT. The announcement cites prior DESTINY-PanTumor02 ovarian cohort data showing clinically meaningful, durable responses in previously treated patients and notes HER2 expression in up to 55% of ovarian cancers, a 5-year survival of 31.8% for advanced disease, and 70–80% recurrence rates after standard treatment.
Salesforce (NYSE: CRM) announced on December 4, 2025 that AstraZeneca (AZN) selected Agentforce Life Sciences for Customer Engagement as its unified global platform to transform customer engagement with healthcare professionals.
The collaboration expands Agentforce 360 for Life Sciences to provide medical-commercial coordination, personalized next-best-action engagement, multi-channel campaign orchestration, and Model Context Protocol (MCP) interoperability via Salesforce’s Agent Fabric.
The companies say the platform aims to improve strategic customer outcomes, streamline field engagement, and support AstraZeneca’s work across oncology, rare diseases, cardiovascular, renal and metabolism, and respiratory and immunology.
AstraZeneca (AZN) will present its largest-ever hematology program at the 67th ASH Annual Meeting, December 6–9, 2025, with 65 abstracts across eight approved and investigational medicines and 15 oral presentations. Key highlights include a three-year follow-up Phase I study of surovatamig (CD19xCD3 T-cell engager) in relapsed/refractory follicular lymphoma, initial DURGA-1 data for AZD0120 (BCMAxCD19 CAR T) in relapsed/refractory multiple myeloma, 50-month ECHO results for CALQUENCE in first-line mantle cell lymphoma, and Phase III pediatric data for ULTOMIRIS in HSCT-associated thrombotic microangiopathy. Additional abstracts cover safety, subgroup analyses, real-world evidence, and other investigational assets.
AstraZeneca (NYSE:AZN) announced the US FDA has accepted the New Drug Application for baxdrostat under Priority Review for adults with hard-to-control hypertension, with a PDUFA target in Q2 2026. The NDA is based on the BaxHTN Phase III trial (n=796) that met primary and all secondary endpoints, showing placebo-adjusted seated systolic BP reductions of 9.8 mmHg (2 mg) and 8.7 mmHg (1 mg) at week 12. Baxdrostat was generally well tolerated and is being studied across a program of >20,000 patients for hypertension, primary aldosteronism, CKD and heart failure combinations.